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NeoGenomics, Elevation Oncology Partner on NRG1 Fusion Testing for Clinical Trial Enrollment

NEW YORK – NeoGenomics and Elevation Oncology said on Tuesday that they have signed an agreement to help identify patients with any solid tumor who have an NRG1 fusion and may qualify for enrollment in Elevation's Phase II CRESTONE study.

The CRESTONE trial is exploring the activity of the HER3 monoclonal antibody seribantumab in NRG1 fusion-positive tumor patients. While NRG1 fusions occur only in 0.2 percent of solid tumors, Elevation aims to enroll 76 patients with a range of tumor types in the trial.

Elevation has also partnered with Caris Life Sciences, Strata Oncology, and Ashion Analytics to test patients for NRG1 fusions in order to determine their enrollment eligibility for the trial.

NeoGenomics' gene fusion panels apply RNA sequencing to spot translocations and fusions with known and novel fusion partners across solid tumors, including actionable fusions involving NRG1, ALK, BRAF, FGFR, PDGF, RET, and ROS1.

"Our collaboration with Elevation Oncology reflects our shared pursuit of matching cancer patients to clinical trials and therapies that are precisely targeted to their unique tumor types and genomic biomarkers," Douglas VanOort, chairman and CEO of NeoGenomics, said in a statement. "Through cross-industry collaborations, we enable greater efficiency in the development and delivery of the latest advancements in both diagnostics and targeted therapies."

Financial details of the agreement were not disclosed.

"Accurate and widespread identification of gene fusions is critical to ensure patients can be matched to the growing number of approved and investigational precision therapies for these key oncogenic drivers," Shawn Leland, founder and CEO of Elevation Oncology, said in a statement. "We are pleased to partner with NeoGenomics to ensure that across any solid tumor, each positive NRG1 fusion test result has the potential to be met with an actionable therapeutic opportunity in our Phase II CRESTONE study."

Elevation raised $65 million in November to help complete enrollment in the CRESTONE trial.